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Pluristem Receives Israeli Ministry of Health Approval to Expand Its Phase II Clinical Trial in Intermittent Claudication to



Pluristem Receives Israeli Ministry of Health Approval to Expand Its Phase II
Clinical Trial in Intermittent Claudication to Israel

International Study Extends FDA Phase II Trial That Began in U.S.

HAIFA, Israel, Oct. 2, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc.
(Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell
therapies, announced today that the Israeli Ministry of Health has approved
the company's request to initiate a Phase II study using its PLacental
eXpanded (PLX) cells in the treatment of Intermittent Claudication (IC), a
subset of peripheral artery disease (PAD). This approval is part of the
company's previously announced strategy to conduct a multi-national study for
this indication. The protocol will be the same one used for the study
previously approved in the U.S.

Zami Aberman, Chairman and CEO of Pluristem stated, "We are excited to receive
the Ministry of Health approval for our clinical study in Israel. This also
marks the first clinical study in Israel to use off-the-shelf allogeneic,
placental-derived cells. Additionally, the professional review of this
clinical trial application by the Israeli Ministry of Health will provide a
solid foundation for Pluristem to conduct additional studies in Israel."

About the Study

Pluristem's IC Phase II is a randomized, placebo-controlled trial that will
evaluate the safety and efficacy of two doses of PLX-PAD cells versus placebo,
administered via intramuscular injections. The study protocol is comprised of
approximately 150 patients with IC: Fontaine class IIb, Rutherford category
2-3.

The primary efficacy end point of the trial is the change in the maximal
walking distance from baseline during an exercise treadmill test. Secondary
endpoints are hemodynamic and quality of life measurements. Safety parameters
are also being assessed.

About Intermittent Claudication

IC is a subset of PAD caused by atherosclerosis of the lower extremity
arteries. IC is characterized by muscle pain, such as aching, cramping,
numbness or a sense of fatigue classically in the calf muscle, which occurs
during exercise, such as walking, and is relieved by a period of rest. The
prevalence of IC in the United States alone is approximately 14 million
patients and representing a cost of approximately $2.5 billion annually to the
National Healthcare Bill (References: The SAGE Group and HCUP 2007 Inpatient
Data).

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell
therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug
delivery platform that releases a cocktail of therapeutic proteins in response
to a host of local and systemic inflammatory and ischemic diseases. PLX cells
are grown using the company's proprietary 3D micro-environmental technology
and are an "off-the-shelf" product that requires no tissue matching prior to
administration.

Pluristem has a strong intellectual property position, company-owned GMP
certified manufacturing and research facilities, strategic relationships with
major research institutions and a seasoned management team. For more
information visit www.pluristem.com, the content of which is not part of this
press release.

The Pluristem Therapeutics Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6882

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995 and federal securities laws. For example, when we discuss our study in
Israel and say that the professional review of the clinical trial application
by the Israeli Ministry of Health will provide a solid foundation for us to
conduct additional studies in Israel, we are using forward-looking statements.
These forward-looking statements and their implications are based on the
current expectations of the management of Pluristem only, and are subject to a
number of factors and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. The
following factors, among others, could cause actual results to differ
materially from those described in the forward-looking statements: changes in
technology and market requirements; we may encounter delays or obstacles in
launching and/or successfully completing our clinical trials; our products may
not be approved by regulatory agencies, our technology may not be validated as
we progress further and our methods may not be accepted by the scientific
community; we may be unable to retain or attract key employees whose knowledge
is essential to the development of our products; unforeseen scientific
difficulties may develop with our process; our products may wind up being more
expensive than we anticipate; results in the laboratory may not translate to
equally good results in real surgical settings; results of preclinical studies
may not correlate with the results of human clinical trials; our patents may
not be sufficient; our products may harm recipients; changes in legislation;
inability to timely develop and introduce new technologies, products and
applications; loss of market share and pressure on pricing resulting from
competition, which could cause the actual results or performance of Pluristem
to differ materially from those contemplated in such forward-looking
statements. Except as otherwise required by law, Pluristem undertakes no
obligation to publicly release any revisions to these forward-looking
statements to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events. For a more detailed
description of the risks and uncertainties affecting Pluristem, reference is
made to Pluristem's reports filed from time to time with the Securities and
Exchange Commission.

CONTACT: Pluristem Therapeutics Inc.:
        
         William Prather R.Ph., M.D. Sr. VP Corporate Development
         1-303-883-4954
         William.PratherMD@pluristem.com
        
         Daya Lettvin
         Investor & Media Relations Director
         +972-54-674-5580
         daya@pluristem.com

Pluristem Therapeutics Inc. Logo
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